Method for removing a tattoo through patterned trans-epidermal pigment release

ABSTRACT

Embodiments of a method for removing a tattoo through patterned trans-epidermal pigment release includes determining first treatment area of skin of a patient through a primary template including primary apertures, marking the first treatment area of skin of the patient along borders of the primary apertures to outline a grid of primary tegulae, and delivering a tattoo removal fluid to the marked first exposed skin. In an alternate embodiment, a template, which may be adhered to the skin, is used during a microneedling process to create a structured, patterned procedure to remove skin irregularities. The template has a plurality of needle apertures, an adhesive layer, and a release liner. The release liner may be removed, exposing the adhesive layer, so that the template, with the plurality of needle apertures, may be positioned over the skin irregularity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/261,670 filed on Sep. 9, 2016 and entitled “Method forRemoving a Tattoo Through Patterned Trans-Epidermal Pigment Release,”which application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/216,206 filed on Sep. 9, 2015 and entitled“Tattoo and Tattoo Removal Device and Method.” The contents of eachprior application are hereby incorporated by reference in theirentirety.

BACKGROUND

Tattooing is the process of the introduction of colored inks into thedermis layer of skin to permanently color the skin. The process requiresthe controlled application of the colored inks to the dermis layer of apatient's skin, by repeatedly perforating the epidermis layer of skinwith controlled punctures by needles coated in ink. Once punctured, theskin cells wipe the ink from the surface of the needles, whichessentially stains these cells with the desired pigments.

Tattoos (as well as permanent make-up) can over time be less desirablefor people due to poor design, social Stigma, or life changes (e.g.,career or relationship changes, etc.). Tattoo removal can be difficult,costly, and painful. Improvements in tattoo removal are needed to betterserve a large segment of customers with a less difficult, costly, andpainful removal process.

SUMMARY

The subject matter of the present application has been developed inresponse to the present state of the art, and in particular, in responseto the shortcomings of tattoo removal, that have not yet been fullysolved by currently available techniques. Accordingly, the Subjectmatter of the present application has been developed to overcome atleast Some of the shortcomings of prior art techniques.

Embodiments of a method for removing a tattoo through patternedtrans-epidermal pigment release are described. In one embodiment, themethod for removing a tattoo through patterned trans-epidermal pigmentrelease includes determining first treatment area of skin of a patientthrough a primary template including primary apertures, marking thefirst treatment area of skin of the patient along borders of the primaryapertures to outline a grid of primary tegulae, and delivering a tattooremoval fluid to the marked first exposed skin in a first treatmentsession. The method further includes determining a secondary treatmentarea through a secondary template including secondary apertures, markingthe secondary treatment area along borders of the secondary apertures tooutline a grid of secondary tegulae, and delivering a tattoo removalfluid to the secondary tegulae in a second treatment session. Otherembodiments of a method for removing a tattoo through patterned transepidermal pigment release are described.

Other aspects and advantages of embodiments of the present inventionwill become apparent from the following detailed description, taken inconjunction with the accompanying drawings illustrated by way of exampleof the principles of the invention.

The described features, structures, advantages, and/or characteristicsof the subject matter of the present disclosure may be combined in anySuitable manner in one or more embodiments and/or implementations. Inthe following description, numerous specific details are provided toimpart a thorough understanding of embodiments of the subject matter ofthe present disclosure. One skilled in the relevant art will recognizethat the subject matter of the present disclosure may be practicedwithout one or more of the specific features, details, components,materials, and/or methods of a particular embodiment or implementation.In other instances, additional features and advantages may be recognizedin certain embodiments and/or implementations that may not be present inall embodiments or implementations. Further, in Some instances,well-known structures, materials, or operations are not shown ordescribed in detail to avoid obscuring aspects of the Subject matter ofthe present disclosure. The features and advantages of the subjectmatter of the present disclosure will become more fully apparent fromthe following description and appended claims, or may be learned by thepractice of the subject matter as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS 0008

In order that the advantages of the subject matter may be more readilyunderstood, a more particular description of the subject matter brieflydescribed above will be rendered by reference to specific embodimentsthat are illustrated in the appended drawings. Understanding that thesedrawings depict only typical embodiments of the subject matter and arenot therefore to be considered to be limiting of its scope, the subjectmatter will be described and explained with additional specificity anddetail through the use of the drawings.

FIG. 1 depicts a template including a square pattern of circularapertures and an overlapping rhomboid pattern of circular apertures,according to one or more embodiments of the present disclosure.

FIG. 2 depicts a treatment pattern resulting from three treatmentsutilizing optimally placed templates of a rhomboid pattern of circularapertures, according to one or more embodiments of the presentdisclosure.

FIG. 3 depicts a graphical representation of a diameter to spacing ratiodepicting the amount of uncovered skin area and the amount of overlapskin versus the diameter to spacing ratio of apertures of a template,according to one or more embodiments of the present disclosure.

FIG. 4 depicts a template with a rhomboid pattern of circular aperturesand one row of elongated apertures, according to one or more embodimentsof the present disclosure.

FIG. 5 depicts a template with a rhomboid pattern of non-circular andnon-polygonal apertures, according to one or more embodiments of thepresent disclosure.

FIG. 6 depicts a treatment pattern resulting from a first treatmentutilizing a primary template with a rhomboid pattern of circularapertures and a second treatment using a secondary template with arhomboid pattern of non-circular and non-polygonal apertures, accordingto one or more embodiments of the present disclosure.

FIG. 7 depicts a template with a square pattern of octagonal apertures,according to one or more embodiments of the present disclosure,according to one or more embodiments of the present disclosure.

FIG. 8 depicts a treatment pattern resulting from a square pattern ofoctagonal apertures, according to one or more embodiments of the presentdisclosure.

FIG. 9 depicts a template with a rhomboid pattern of octagonalapertures, according to one or more embodiments of the presentdisclosure.

FIG. 10 depicts a point connected treatment pattern with square tegulae,according to one or more embodiments of the present disclosure.

FIG. 11 depicts a point connected treatment pattern with triangulartegulae, according to one or more embodiments of the present disclosure.

FIG. 12 depicts a template with a rhomboid pattern of circularapertures, according to one or more embodiments of the presentdisclosure.

FIG. 13 depicts a side view of the template of FIG. 12 with a releaseliner detached.

FIG. 14 depicts a top plan view of a circular template, according to oneor more embodiments.

FIG. 15 depicts a top plan view of an oval template, according to one ormore embodiments.

FIG. 16 depicts a top plan view of a template with circular apertures,according to one or more embodiments.

FIG. 17 depicts a top plan view of a template with a plurality of largeneedle apertures, according to one or more embodiments.

It will be appreciated that the drawings are illustrative and notlimiting of the scope of the invention which is defined by the appendedclaims. The embodiments shown accomplish various aspects and objects ofthe invention. It is appreciated that it is not possible to clearly showeach element and aspect of the invention in a single figure, and asSuch, multiple figures are presented to separately illustrate thevarious details of the invention in greater clarity. Similarly, notevery embodiment need accomplish all advantages of the presentinvention.

While the disclosure is susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and will be described in detail herein. However,it should be understood that the disclosure is not intended to belimited to the particular forms disclosed. Rather, the intention is tocover all modifications, equivalents and alternatives falling within thespirit and scope of the invention as defined by the appended claims.

Throughout the description, similar reference numbers may be used toidentify similar elements.

DETAILED DESCRIPTION

It will be readily understood that the components of the embodiments asgenerally described herein and illustrated in the appended figures couldbe arranged and designed in a wide variety of different configurations.Thus, the following more detailed description of various embodiments, asrepresented in the figures, is not intended to limit the scope of thepresent disclosure, but is merely representative of various embodiments.While the various aspects of the embodiments are presented in drawings,the drawings are not necessarily drawn to scale unless specificallyindicated.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by this detailed description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their Scope.

Reference throughout this specification to features, advantages, orsimilar language does not imply that all of the features and advantagesthat may be realized with the present invention should be or are in anysingle embodiment of the invention. Rather, language referring to thefeatures and advantages is understood to mean that a specific feature,advantage, or characteristic described in connection with an embodimentis included in at least one embodiment of the present invention. Thus,discussions of the features and advantages, and similar language,throughout this specification may, but do not necessarily, refer to thesame embodiment.

Furthermore, the described features, advantages, and characteristics ofthe invention may be combined in any suitable manner in one or moreembodiments. One skilled in the relevant art will recognize, in light ofthe description herein, that the invention can be practiced without oneor more of the specific features or advantages of a particularembodiment. In other instances, additional features and advantages maybe recognized in certain embodiments that may not be present in allembodiments of the invention.

Reference throughout this specification to “one embodiment,” “anembodiment,” or similar language means that a particular feature,structure, or characteristic described in connection with the indicatedembodiment is included in at least one embodiment of the presentinvention. Thus, the phrases “in one embodiment,” “in an embodiment,”and similar language throughout this specification may, but do notnecessarily, all refer to the same embodiment.

While many embodiments are described herein, at least some of thedescribed embodiments allow for the efficient removal of tattoos,permanent makeup, and other indelible mark or pigment on and under theskin. Some embodiments minimize retreatment overlap of tattooed skin.Some embodiment allow for efficient isolating of tattooed skin tiles(tegulae) for a final removal treatment. Some embodiments provide forfront-loading removal of a tattoo in the first treatment. Someembodiments reduce the total number of treatment sessions. Someembodiments reduce the potential for scarring. Some embodiments areunaffected by skin movement and skin stretch.

While description herein refers primarily to tattoo removal, theapparatuses, systems, and methods described herein may be also beutilized for tattooing or other application of inks, etc., to the skinof a patient.

Trans-epidermal pigment release (TEPR) is a non-laser process forremoving tattoo ink that employs partial thickness dermal injuries toinitiate a beneficial healing response. These are Superficial injuriesthat penetrate into but not through the dermis. The beneficial responseis the formation of an eschar or debris-scab of necrotized dermaltissue. Tattoo ink is pushed out of the skin from below by the healingand regenerating epidermis and dermis.

U.S. Pat. No. 8,663,162 (Tattoo Removal System, 162 patent) describes asystem for the controlled delivery of an eschar inducing material (EIM)via a pump to a handpiece with reciprocating needles, like those used ina tattoo machine. The combined mechanical injury (via the penetratingneedles) and chemical injury (via the EIM) removes all epidermal cells,disrupts the dermal structure to a specified depth, and effectivelyinitiates eschar formation. Subsequent healing completely removes thetattoo ink (independent of color and composition) from the injury site.

TEPR is most effective when injuries are localized to areas of skinbordered by uninjured skin. Embodiments described herein utilizetemplates to outline treatment areas of the skin and limit them to aspecific size and shape that balances the need for bordering uninjuredskin and a sufficient area to apply the TEPR process.

Keratinocytes are the cells responsible for the structure and barrierfunctionality of the cellular epidermis. A fresh wound (lacking aprotective epidermis) is quickly covered by proliferating keratinocytesspreading (beneath the temporary scab) from non-necrotized, borderingtissue. The bordering uninjured skin is important to the healingprocess.

A wound becomes fully epithelialized when the thin layer ofkeratinocytes completely recovers the wound. This typically occurswithin 2 to 3 weeks of the injury. After epithelialization is complete,the stratified layers of keratinocytes (found in mature epidermis)regenerate, while other cells in the dermis rebuild the underlyingdermal matrix structure. Epidermal maturation requires months forcompletion, such as 8 to 12 weeks. The underlying dermal matrix israpidly rebuilt with oriented fibers (characteristic of tough scartissue), which are later remodeled over years into more pliable tissue.During dermal rebuilding, visible and hypertropic (raised) scars canform depending on the depth of the wound, genetic Susceptibilities, andaftercare (such as attempting to control trans-epidermal water loss anddermal stresses).

Keratinocytes proliferate to cover a fresh wound at rates determined bythe natural growth and cell-cycle time governing mitosis (non-gameticcellular division). Thus, when the minimum linear or areal extent of thewound is large, epithelialization is delayed. This can result infibrosis, hypertrophic scarring, and poor healing. The goal of TEPR isto produce wounds in spatial patterns that are conducive to both healingand eschar formation. When wounds are too Small, ink-agglomeratingeschars will be limited or will not form. When wounds are too large, theskin will be damaged and scarring will prevail. Embodiments describedherein utilize templates (see e.g., FIGS. 4, 5, and 7 ) to markpotential treatment areas to optimize the size and shape of wounds.

Unlike laser treatment, TEPR removes all tattoo ink at the treatmentsite in a single session. Because TEPR treatment always occurs locallyat sites bordered by untouched skin, tattoos must be removed piecemeal.A series of treatment sessions, each separated by inter-session healingperiods (lasting approximately from 8 to 12 weeks), are utilized tocompletely remove a full-area tattoo, in which the entirety or greatermajority of the skin is tattooed. Modern multiple-color tattoos aretypically full-area tattoos.

Embodiments of an advanced TEPR series accomplish various goals tooptimize treatment during tattoo removal. Embodiments minimizeoverlapping retreatment areas to minimize dermal sensitization,inflammatory reaction, and the potential for visible scarring.Embodiments deal effectively with the vagaries of manual treatment by,for example, automatically compensating for skin movement and stretch.Finally, embodiments allow for completion of the removal process in aminimum number of treatment sessions.

Embodiments of an advanced TEPR process simultaneously accomplish Someor all of these goals. The fundamental idea is the divide the tattooedsurface into skin tiles that completely cover the skin with minimaloverlap and remove evenly spaced skin tiles (tegulae) in a series oftreatment sessions. To accomplish this, treatment sites in the shape ofonly the circular disks (as disclosed by the 162 patent) cannot be usedfor all treatment sessions. The treatment sites of skin tiles may becalled tegulae (singular, tegula, and adjective form, tegular). Theetymological derivation of the name literally means “skin tile’, beingtaken from the ancient Roman “imbrex and tegulae’ roof tiling system andskin as the “tegument of the body.

In contrast to some methods with overlapping treatment sites,embodiments of an advanced TEPR process break up a surface intotheoretical tegulae that fully cover the Surface without overlap. Sometegulae in a series may be circular, but not all. Tegulae may be round,square, hexagonal, triangular, polygonal, arbitrarily shaped,curvilinear, or a combination of polygonal and curvilinear. A completetiling series may contain just one kind of tegula (see e.g., FIGS. 10and 11 ) or many different shaped and sized tegulae 600 (see e.g., FIG.6 ) in combination.

Each session in a series treats some tegulae and leaves others intact.For any particular session, treated or “excised tegulae are calledextegs, while intact or “integral tegulae are called integs. Tegulaethat are extegs in one session are integs in other sessions, and viceversa.

To prevent leaving bordering halos of ink, in some embodiments,pragmatic extegs may be slightly larger than their theoreticalcounterparts; in other words, pragmatic excised tegulae are minimallyoverlapping.

Referring to shortcomings of traditional treatment patterns and process,FIG. 1 depicts a template 100 including a square pattern 102 of circularapertures 104 (represented with a hatch from upper right to lower left)and an overlapping rhomboid pattern 106 of circular apertures 120(represented with a hatch from upper left to lower right). The 162patent describes templates for applying a TEPR pattern to tattooed skin(the 162 patent, FIG. 8, and claims 1, 7, and 8). TEPR treatment sites(called “dots” in the 162 patent) are disk-shaped areas marked on theskin through template holes called apertures. Circular aperturediameters (d) may range from 3 to 6 mm, with 5 mm being preferable. Theseparation (h) between template apertures may range from 2 to 5 mm, with3 mm being preferable. FIG. 1 depicts a scale on the X-axis and y-axisin millimeters.

The 162 patent does not specify any particular pattern or aperturearrangement, but merely describes a template with “constant diameter and“uniformly spaced circular apertures.” This description admits acontinuum of regular templates. All place circular apertures on gridline intersections, or equivalently, at the vertices of rhomboidal unitcells that define the grid (see e.g., FIG. 1 ). A rhomboidal unit cellhas the shape of a general rhombus or equilateral parallelogram.Equilateral unit cells ensure uniform aperture spacing.

With apertures aligned in a square grid, the generalized rhomboidal unitcell becomes a square (with side s-d-h). When adjacent rows of aperturesare horizontally shifted, square unit cells become skew rhomboidal ordiamond shaped (see e.g., FIG. 4 ). This shifting decreases the rowspacing, compacts the arrangement, and favorably increases theaperture-to-unit-cell area ratio. Because each rhomboidal unit cellcontains exactly one quadrisected aperture, this area ratio exactlyequals the fractional coverage of one pattern application. For the sameaperture diameter and spacing, a more compact arrangement will yield alarger factional coverage, which means that more of the tattoo can beremoved in a single treatment session.

The least compact regular arrangement is the square grid. The mostcompact arrangement occurs with rows shifted so their grid points lieexactly between adjacent row grid points (see e.g., FIG. 4 ). Thisproduces a rhomboidal unit cell composed of two equilateral triangles,which defines the grid. It is sometimes referred to as a hexagonallattice, so named because each grid point is equidistant from sixneighboring grid points.

FIG. 8 of the 162 patent shows a template with circular apertures on ahexagonal lattice. Other drawings (such as FIGS. 9-11 of the 162 patent)show how this rhomboid pattern can be shifted and reapplied to fullycover the area in a series of three treatment sessions (see also e.g.,FIG. 2 of the current application showing primary tegulae 202 for thefirst treatment session, secondary tegulae 204 for the second treatment,and tertiary tegulae 206 for the third treatment). FIG. 2 furtherdepicts a scale on the x-axis and y-axis in millimeters.

A similar series of treatment sessions is required to fully cover anarea with a square grid pattern, but in this case four sessions arerequired. Treatment sessions in a series may be named by order: primary,secondary, tertiary, qua ternary, quinary, etc.

Although not explicit, the square grid pattern is also implied in the162 patent disclosure, where a series of four treatment sessions isdeemed necessary for full removal: (162 line 2:19) “approximately, foursuch treatment session are generally required, and then (162 line 2:37)“an average number of treatments is at least four to eight’ depending ontattoo size. Because large tattoos are typically divided into twotreatment areas, the latter implies four sessions per treated area, aswould be required by a Square grid pattern.

Years of experience with the classic pattern (i.e., 5 mm diameter disks,centered on hexagonal lattice points and spaced 8 mm apart) have shownthat the template is necessary and effective in providing the properpattern spacing. Further, when a template is not used during the primarytreatment session, Subsequent sessions in the removal series aretechnically more difficult. In addition to the three required coveringssessions for a hexagonal lattice pattern, one to three extra sessionsare always required to completely remove the remnants of a full-areatattoo. As a consequence, skin stretching, subsequent patternapplications may be distorted with respect to those laid out in earliertreatment.

Yet, even if skin did not stretch and the theoretical pattern wasapplied perfectly each time, several extra treatment sessions wouldalways be necessary because of a design defect not recognized by theinventors. The 162 patent calls for a series of treatments with the samepattern shifted to cover untreated skin left intact by prior treatments.Yet, even when this is done perfectly, the preferred design leavesuncover defects 208 (see e.g., FIG. 2 ), where the skin is notTEPR-treated and where the tattoo is not removed even after threetreatment sessions. To remove these uncover defects 208 requires severalextra treatment sessions.

Although small, these triangle-shaped tattoo remnants (e.g., 208) arenumerous. For a rhomboid pattern there are six times as many defects aspattern apertures. Because these defects are uniformly distributed, theyrequire multiple treatments for removal.

Eschar formation and pigment release may be inhibited when treatmentdisks are too small. Thus, a strategy for removing Small defects is togroup them together. Yet, because they are uniformly distributed, onlytwo defects fit within a standard 5 mm treatment disk. The six defects(per pattern aperture) may thus require as many three extra treatmentsto completely remove the tattoo remnants. This doubles the total numberof treatments required. The three extra treatments are also moretechnically difficult that the original three, because the same patchesof skin must be retreated.

Human skin never regenerates its virgin state. Scar tissue naturallyforms as injuries heal. Tattooing and tattoo removal generate scartissue, which when significant or hypertrophic appears as visible Scars.One great advantage of TEPR treatment over laser removal is that a patchof tattooed skin need only be treated once. (The average laserremoval—one treatment followed by nine retreatments—substantiallydestroys the pliable dermal substructure.) Extra TEPR retreatmentsdiminish this advantage. Additionally, skin becomes sensitized to TEPRtreatment and to the EIM used. As a consequence, retreated skin reactsstronger and generates more scar tissue. In a perfect TEPR process,retreatment would be avoided.

To better understand the nature of the design defect, it is useful toplot theoretical uncover 306 and overlap 308 functions (see e.g., FIG. 3) with respect to the aperture diameter-to-spacing ratio (d/s) 302.Uncover 306 is the area fraction 304 remaining untreated after the fullTEPR series is complete. For rhomboid patterns of circular apertures, afull series consists of 3 treatment sessions. For square grid patterns,a full series consists of 4 treatment sessions. Overlap 308 is the skinarea fraction 304 retreated multiple times. An optimal strategy foreffective tattoo removal minimizes overlap 308 while Zeroing uncoveredarea.

FIG. 3 shows that, for all rhomboid patterns of circular apertures,uncover 306 cannot the Zeroed without incurring significant overlap 308.Uncover 306 and overlap 308 functions for all square patterns aresimilar but worse: much more overlap is required to Zero out the uncoverarea.

The diameter-to-spacing ratio (d/s) 302 is a crucial parameter thatdetermines the uncover 306 and overlap 308 of the treatment series for aparticular pattern. For rhomboid patterns of circular apertures, uncoveris Zeroed only when d/s-⅔. This was not recognized in the 162 patent,wherein the possibility of uncover defects was not even mentioned.

The 162 template drawing (162 FIG. 8) and treatment series snippets (162FIGS. 9, 10 and 11) were not drawn to scale. As shown, the templatediameter-to-spacing ratio is close to one-half (d/ss0.5), which issignificantly smaller than the preferred design (162 column 8, lines27-30), where d/s=⅝. In contrast, the treatment series Snippets used todemonstrate complete coverage (with d/ss0.7) exceed the preferreddesign.

Given the design range provided by the patent (162 claim 1) with 3sds6and 2shs5 mm, the criterion to Zero the uncover can be satisfied forrhomboid patterns of circular apertures with 6 mm apertures spaced lessthan 3 mm apart, but this was not recognized by the 162 patent.

The minimal requirement for any useful TEPR series is complete coverageof the tattooed skin. (This assumes the most difficult case, which isthe removal of a full-area tattoo. Obviously, when removing partial-areatattoos, or when selectively modifying tattoos in preparation for acover-up tattoo, this requirement can be relaxed.)

In embodiments of an advanced TEPR process, referring to FIGS. 4-6 , afirst treatment session may include the use of template 400 with arhomboid pattern (see e.g., 608 of FIG. 6 ) of circular apertures 402. Asecond treatment session may include the use of template 500 with arhomboid pattern of a non-circular and non-polygonal apertures 502. Thearray of non-circular and non-polygonal apertures 502 would align withthe circular apertures 402 as shown by dotted line circle 504 in FIG. 5. A third treatment session would remove the remaining isolated tegulaemarked by remnant tattoo ink. The template 400 may be a sheet ofmaterial with a plurality of apertures spaced in a repeating pattern. Insome embodiments, the sheet of material is configured to be flexible toconform to a non-flat surface of skin of a patient. In some embodiments,the sheet of material is configured to be flexible while not stretching.That is, the distance between apertures does not increase throughstretching in a transverse direction between the apertures.

In one embodiment, the circular apertures 402 are 5 mm diameter disks,spaced 8 mm apart. The circular apertures 402 combine to coverapproximately 35 percent of a unit cell (represented by rhombus 608 inFIG. 6 ). The remaining 65 percent is split evenly between secondarytegulae 604 and tertiary tegulae 606. These extegs are triangulations ofthe hexagonal lattice, minus the primary disks. That is, the secondarytegulae 604 (i.e., the treatment area for the second treatment session)and tertiary tegulae 606 (i.e., the treatment area for the thirdtreatment session) are combinations of a polygonal shape (triangle) anda curvilinear shape (excised segment of a circle). The triangle isformed with vertices at the center of the circular apertures and thecorners of the triangle are removed as segment of the circularapertures. The shape formed is the non-circular and non-polygonalapertures 502 depicted in FIG. 5 .

How extegs are excised is the differentiator between overlapping and anadvanced TEPR process. The primary treatment is identical for both:utilizing the template 400 to determine a first or primary treatmentarea of skin. The template 400 and apertures 402 guide a skin markingpen as exposed skin of a patient (through the template 400) is markedalong the borders of the circular apertures 402. The skin could bemarked by any of a number of apparatuses in any number of waysincluding, for example, spray on ink from an airbrush which may bedriven with canned air or by an external pressurized air system. Ahandpiece (or actuating device and needle cartridge) (supplied with acontrolled flow of EIM) is then used to score each marked primary tegula(see e.g., 602 in FIG. 6 ). This process gray lines the circular primarytegulae 602. The skin is then cleaned removing all the markings exceptthe gray lined primary tegulae 602. The handpiece is then used to exciseeach primary tegulae 602, removing all epidermal cells until the denselyinked reticular dermis is uncovered. The excision also sharpens anddefines tegular boundaries and disrupts the interior dermal structure,both mechanically and chemically.

In an advanced TEPR process, secondary and tertiary treatments differmarkedly from the primary treatment, especially during the all-importantexcision pass. Secondary tegulae 604 are marked with the template 500shown in FIG. 5 . The broken circles (represented by dotted line circle504) in the template 500 are aligned with the primary tegulae 602, whichnow (after the healing process) markedly stand out as healed fresh skin,polka-dotting the inked tattoo. The template 500 may be readjusted asnecessary so that broken circles are always aligned near the primarytegulae 602 being marked.

Scoring proceeds in a manner similar to what is described above. Afterthe skin is cleaned, excision proceeds as usual except when sharpeningexteg borders. These borders are defined be the primary tegular disks(the healed polka dots) and theoretical lines connecting their centers.Although unmarked, borders are easily visualized as mental constructionsconnecting the healed polka dots. Care may be taken to TEPR-treat allinked skin within these borders. It is this important proceduraldifference that eliminates all uncover defects (see e.g., 208 of FIG. 2) and compensates for skin movement and stretch.

In effect, the healed primary tegulae 602 act as permanent alignmentmarkers that directly define the exteg pattern of the secondary tegulae604. Even so, the secondary tegulae 604 cannot be easily identified andmarked without the secondary template 500. Attempting to mark them byeye (without a guide), results in mistakenly marking an integ (i.e., thetertiary tegulae 606) as an exteg for the second treatment session.Every mistake puts two extegs together, which would result in removingbordering tertiary tegula 606 and secondary tegula 604. The size mayprevent their removal. Such mistakes may force an extra retreatmentsession.

After the primary and secondary treatments, all the remaining tattoo inkis sequestered within the tertiary tegulae 606. The third treatment doesnot require any template whatsoever as the tertiary tegulae 606 areisolated ink. One simply treats the remaining ink. That is, the nowhealed primary tegulae 602 and the now healed secondary tegulae 604 formisolated ink patterns (i.e., the tertiary tegulae 606). FIG. 6 depicts agrid of primary tegulae 602 (i.e., the grid of right hatched circles), agrid of secondary tegulae 604 (i.e., the grid of left hatch non-circularand non-polygonal shapes), and a grid of tertiary tegulae 606 (i.e., thegrid of non-circular and non-polygonal shapes that are not hatched. Asdepicted, each of the primary tegulae 602 border three secondary tegulae604 and three tertiary tegulae 606, each of the secondary tegulae 604border three primary tegulae 602 and three tertiary tegulae 606, andfinally each of the tertiary tegulae 606 border three primary tegulae602 and three secondary tegulae 604. The secondary tegulae 604 and thetertiary tegulae 606 are the same shape. The process described inconjunction with FIG. 6 results in a tattoo removal requiring only threetreatment session.

Because TEPR locally treats skin in areas bordered by intact skin, thereare fundamental constraints limiting the possible patterns and seriesuseful in tattoo removal. All TEPR tiling series can be categorized asskin-bridge series (see e.g. FIG. 6 ), skin-island series (see e.g.,FIGS. 8 and 9 ), or point-connected series (see e.g., FIGS. 10 and 11 ).There are no other possibilities, except for lateral and nestedcombinations of these three.

In skin-bridge series, extegs (i.e., the tegulae corresponding to theparticular treatment session) are disconnected from each other, beingisolated by an enclosing network of integs (the other two tegulae notcorresponding to the particular treatment session). Integs form theuntreated skin bridges that Surround and isolate extegs from oneanother. For example, the secondary tegulae 604 and the tertiary tegulae606 together form untreated skin bridges (Surrounding the primarytegulae 602) during the first treatment session. The primary tegulae 602and the tertiary tegulae 606 together form untreated skin bridges(surrounding the secondary tegulae 604) during the second treatmentsession. And finally, the primary tegulae 602 and the secondary tegulae604 together form untreated skin bridges (surrounding the tertiarytegulae 606) during the third treatment session.

FIG. 6 illustrates a useful skin-bridge tiling series. (Although not atiling series, the classic overlapping pattern defined by US patent 162and illustrated by FIG. 1 also forms a skin-bridge series.) The minimumnumber of treatment sessions required to complete a skin-bridge tilingseries is three sessions.

One exception to this rule for skin-bridging series concerns removalareas where individual tegulae can be elongated to span the entire wideof the area. In this case, the removal area can be covered in twotreatments with a striped tiling pattern.

Striped skin-bridge series are a subset of skin bridge series processes.A striped pattern, where equal height tegulae span the entire removalarea can tile an elongated area in two sessions. The template used tolayout the primary pattern is a series of rectangular slots or elongatedelliptical slots (see e.g., elongated apertures 404 in FIG. 4 ) in alinear pattern. FIG. 4 further depicts a scale on the X-axis and y-axisin millimeters.

Striped patterns are particularly advantageous when treating linework.In this case, tegulae are narrowed and elongated (tegula area remainingabout the same) to efficiently cover a narrow line in two treatments.The resulting, linearly elongated, striped pattern is called a linearpattern. A linear template of two or more elongated apertures 404 can beused to lay out a striped pattern along straight and/or curvilinearlines. An example is illustrated as the bottom row of the template shownin FIG. 4 .

A particular advantage of striped patterns used to cover large areas isthe possibility of aligning the stripes with the natural structuralorientation of the underlying dermis. Oriented incisions are routinelyused in plastic Surgery to promote healing and minimize scarring.Striped orientations (parallel to the flowing pattern of Langer lines)can be used to promote healing and minimize scarring in tattoo removal.

In skin-island series, extegs are connected in a lattice network thatisolates integs as secondary tegulae 804. FIGS. 8 and 9 illustrateuseful skin-island tiling series. To better understand and alleviate thedermal stresses that develop during healing, an exteg net isconceptually decom posed into linear (or curvilinear) lanes andinterconnecting nodes. Skin-island series are a kind of reverse ornegative to skin-bridge series. In both, extegs are bordered by intactskin, whether in the form of skin-bridges or skin-islands. Skin-islandseries are interesting because some can be completed in the minimumpossible number of treatment sessions, which is two sessions.

Referring to FIG. 7 , the template 700 with a square pattern ofoctagonal shaped apertures 702 is utilized as a negative template(rather than positive) in that it directly marks the integs and not theextegs. The primarily treated or excised area (i.e., the primary latticetegulae 802) is depicted as hatched and is treated during the firsttreatment session while leaving the secondary tegulae 804 as integs.

The fundamental idea underlying all skin-island series is to isolateeasily removable integs (the skin islands, see e.g., secondary tegulae804 in FIG. 8 or secondary tegulae 904 in FIG. 9 ) by completelysurrounding them with a lattice network of extegs (represented byhatched area 802) which form a primary lattice tegulae 802. Bothsecondary tegulae and the primary lattice tegulae (e.g., 802 and 902)should be shaped so they can be readily TEPR-treated. Both embodimentsdepicted in FIGS. 8 and 9 satisfy these basic requirements.

Skin-islands series are interesting because they can completely remove atattoo in one less treatment than the best skin-bridge series. Only twotreatments are required to complete a skin island series. Thus, bothprimary and secondary treatments should excise approximately equal areasof skin. The two series illustrated (FIGS. 8 and 9 ), evenly divide theunit cell area 806, 906.

The primary lattice tegulae (e.g., 802 and 902) is conceptually composedof straight lanes and interconnecting nodes. One problem with longlinear TEPR excisions (as depicted in FIG. 8 ) is the potential forgenerating long linear Scars. Uniform cross stresses (contractivetensions across the wound) develop as long linear tegulae heal. Incontrast, more compact wounds typically do not produce visible Scars.Linear Scarring is avoided because the stresses developed during healingare more isotropic.

A couple techniques can be used to break up the long linear regions ofcross stress. FIG. 8 illustrates an approach. The enlarged and nearradially-symmetric nodes produce near isotropic stresses during healing.These break up the cross stresses in the extended lanes. As a result,the potential for long linear scarring is reduced. FIG. 9 illustrates anadditional technique of offsetting lanes and thereby breaking up longlinear features in one direction.

Lattice tegulae (e.g., 802 and 902) are designed to be easilyconstructed. Parallel lines are excised in perpendicular directions toform a square grid. Integ corners are next clipped to form the enlargednodes. Clipping is also valuable in making the octagonal integs morecircular and thereby easier to excise in the second treatment session.

Extended exteg lanes can be marked with a template consisting ofparallel linear apertures, like those used to layout Striped patterns.One set is marked, the template is rotated a quarter turn, and then thesecond set is marked. Alternately, a negative template can be used tooutline the pattern (see e.g., FIG. 7 ). It is negative template in thesense that integs rather than extegs are marked at the boundary of theoctagonal apertures 702.

Secondary treatments do not require templates, because the remainingtattoo ink has already been sequestered within easy to remove octagons.The pattern is the ink itself.

One of the major accomplishments of advanced tiling series isminimization of the total number of treatment sessions required for fulltattoo removal. This is important because the healing response ofSubsequent treatment sessions is reduced with each treatment. Clientpressures to remove the unwanted tattoo rapidly, typically cause removalsessions to be scheduled with the minimum intersession healing period(typically 8 to 12 weeks). Although the epidermis has reformed, the skinis still maturing and remodeling and will do so for many months and evenyears. As a consequence, Subsequent treatments (especially withoverlapping patterns) inadvertently (or purposely) retreat newly healedskin with a Subsequent loss in the healing response.

Because the first treatment always heals best, more skin should betreated first. Thus, an advanced series will purposely decrease thefractional area treated with each session. The table below givespossible removal sequences for both 3-session and 2-session series. Inevery case, the total area treated exceeds unity because of minimaloverlaps that are pragmatically required.

All the tiling patterns discussed (including those discussed inconjunction with FIGS. 4-9 ) can be adjusted to optimize the amount ofskin treated in the first and subsequent sessions.

Tiling series Area fraction removed Overlap fraction 3-session series0.50 + 0.35 + 0.25 0.10 2-session series 0.60 + 0.45 0.05

In point-connected series, extegs and integs are mathematicallypoint-connected at common vertices (see e.g., 1006 in FIGS. 10 and 1106in FIG. 11 ). Extegs (e.g., primary tegulae 1002, 1102 for the firsttreatment session) are not adjacent to other extegs (that is, they haveno common borders), and integs (e.g., secondary tegulae 1004, 1104 forthe first treatment session) are not adjacent to other integs. FIGS. 10and 11 illustrate two point-connected tiling series, which are shapedlike regular checkerboards with square 1000 (e.g., FIG. 10 ) andtriangular tegulae 1100 (e.g., FIG. 11 ). In practice, point-connectedseries degenerate to skin-island series by erosion at thepoint-connected vertices. If vertex erosion does not occur duringexcision, it will occur during healing.

Alternatively, point-connected series can be modified with extra vertextegulae to prevent vertex erosion. The resulting patterns form usefulskin-bridge series.

Skin island series are advantageous because they can completely remove afull-area tattoo in just two TEPR treatments. Point-connected series areanother class of two treatment series are based on checkerboardpatterns: either square tegulae (FIG. 10 ), or triangular tegulae (FIG.11 ). Both are shown with the same lattice spacing (s=5 mm).

Although theoretically point-connected tegulae produce a new class oftilings (distinct from both the skin-bridge and skin-island series),pragmatically they always degenerate to skin-island series. This occurseither during excision or Subsequent healing when the theoretical pointconnections at tegulae vertices 1006, 1106 erode and broaden into lanes.TEPR treatment always necrotizes bordering epidermis out to somefraction of a millimeter. Thus, point connections, if they could beconstructed, would only be temporarily constructed of dying skin.Point-connected checkerboard extegs become large nodes connecting ategular net.

Vertex erosion can be inhibited with a three-treatment series. Theprimary treatment places circular tegula at each theoretical pointconnection. Secondary and tertiary treatments then take out the hatchedand unhatched tegulae. The result is a skin-bridge series. In fact, theembodiment depicted in FIG. 6 does just this. Point-connected series,which stand uneasily between skin-bridge and skin-island series, willeither fall into the latter, or can be pushed into the former.

For TEPR tattoo removal, the advanced TEPR process provides Substantialadvantages over overlapping series (e.g., FIG. 2 ). Advanced TEPRprocesses are full covering. Because they tile a Surface, tiling seriescan completely cover a full-area tattoo without leaving the uncoverdefects inherent in overlapping patterns. Advanced TEPR processesminimize retreatment overlap and thereby, inflammation is minimized andthe potential for visible scarring is reduced. Advanced TEPR processesare unaffected by skin movement and stretch. Primary healed tegulae areutilized as permanent markers for aligning and defining intermediatetreatments (secondary tegulae in skin bridge series). Advanced TEPRprocesses use templates for accurate layout. Primary and intermediatetreatment patterns use templates to ensure accurate layout andalignment. Advanced TEPR processes isolate final ink. The finaltreatment in a series is technically easy, because all remaining ink haspurposely been sequestered within well-sized and isolated extegs. Nofinal template is required. Simply treat the ink. Advanced TEPRprocesses require a minimum number of treatment sessions. Referring toFIGS. 4-6 , embodiments of skin-bridge series require only threetreatment sessions. Striped skin-bridge series and skin-island series(e.g., FIGS. 8 and 9 ) require only two sessions. Advanced TEPRprocesses reduce the potential for scarring. This occurs becausetreatment overlap is minimized. Potential for exteg-net Scarring inskin-island series can be reduced with enlarged nodes and offset lanes.Advanced TEPR processes have optimizable areas. Because the firsttreatment always heals best, a removal series can be optimized bydecreasing the area treated with each Successive session. Advanced TEPRprocesses, which typically employ different removal patterns for eachsession, are amenable to area optimizing strategies. Advanced TEPRprocesses are flexible. Advanced TEPR processes are defined by tegulaethat tile an area and align to lattices. Lattices can be morphed andresized to accommodate partial-area tattoos and selective removals.Tegulae are simply reshaped to fully cover the tattooed area to beremoved.

The discussion so far has been limited to TEPR series for removingfull-area tattoos, which technically is the most challenging.Nevertheless, in the tattoo industry complete tattoo removal is far lessimportant than tattoo modification. Of particular importance is theselective removal of undesired tattoo elements in preparation for acover-up tattoo.

In this regard, the piecemeal nature of tattoo removal using TEPR isgreatly advantageous. It uniquely provides the tattoo artist with a newand valuable tool for selective erasure. And although tiling patternsare exceedingly valuable in the full-area removal, they are uniquelysuited for selective removal.

Embodiments described herein allow for the construction and use ofcustomized templates. The process for selective removal with regulartemplates is no more involved than full-area removal. Although anyadvanced TEPR process can be used, the embodiment of FIG. 6 is assumed.For the first treatment, the primary template 400 is placed over thetattoo element selected for removal. Only primary tegulae 602 that fallwithin the selected area are marked. Circular tegulae that fall outsideand on element borders are not marked. The removal process is then conducted for the first treatment area. For the second treatment, thesecondary template is aligned with the primary, healed skin, polka dots.Extegs that fall within the selected area are marked and TEPR-treated aspreviously described. Boundary extegs are carefully excised to removeonly the tattoo elements selected for removal. For the final treatment,ink remaining within the selected tattoo element is directly removed.Simply treat the ink.

Advanced TEPR processes associate a set of tiling tegulae with everypoint in a two-dimensional lattice. So far, the lattices described wereall regular, being periodic repetitions of a rhomboidal or square unitcell. For full-area removal, regular lattices are adequate and useful.For selective removal, non-regular lattices (without periodicityconstraints) are sometimes even more useful.

To custom fit a tattooed area selected for removal, lattices can bestretched and continuously morphed and Some portions can be removedaltogether. The tiling tegulae similarly morph to cover the selectedarea without gaps. Although this can be accomplished with any tilingseries, the embodiment described in conjunction with FIG. 6 isparticularly useful and easy to use.

Either morph a two-dimensional lattice or uniformly distribute a set ofpoints to cover the tattoo element selected for removal. Primary tegulaeare circular disks centered on these points. All remaining tegulae aretriangulations of these points with primary disks Subtracted. Latticepoints are not placed on the boundaries of the selected area. Insteadmodified secondary and tertiary tegulae define the boundaries. The onlyother constraint on point location is that every point must have an evennumber of nearest neighbors. A point with an odd number of nearestneighbors, would yield two adjacent extegs. Such odd-neighbor problemsare easily remedied with point additions and subtractions.

Once the points are located, custom templates are made for laying outprimary and secondary treatment tegulae (no tertiary template isrequired, as the remaining ink is isolated). Custom templates can be cutwith computer controlled sheet-cutting machines, or they can be printedand applied as temporary Stick-on tattoos.

As custom templates are computer designed (and then cut or printed), thetattoo geometry must first be input. This data is derived fromphotographs of the tattoo. Required geometric transformations arefacilitated by photogrids.

One problem in using photographs and computers to design tiling patternsand associated templates for selective tattoo removal involvestransformations between the curved surfaces of body parts and the flatrepresentations of the images and templates. Mapping an image from ageneralized curved surface (like a globe) to a flat sheet is a classicproblem that has no perfect Solution: the image is inevitably distortedby whatever mapping is employed.

Fortunately, the great majority of tattoos are placed on body Surfacesthat are curved in only one direction, like the surface of a cone. Suchsurfaces (which everywhere have Zero Gaussian curvature) are said to beintrinsically flat, which means they can be unrolled onto a planeSurface without distortion. A sheet of paper, for example, can (withoutdistortion) be rolled up to form a cylinder or cone.

Although tapered body surfaces are never perfectly flat (in theintrinsic sense), the skin and underlying flesh are pliable andstretchable. This makes it possible to locally apply templates andStick-on tattoos that are perfectly flat (in the intrinsic sense)without folds or distortions in the appliance, which is relativelyunstretchable as compared to skin and flesh. When the appliance ispressed onto the skin, the skin and flesh stretches so that the surfacebecomes intrinsically flat, just like the appliance. In areas where thisis not possible—within concavities or over bony protuberances—theappliance of necessity will wrinkle or fold.

Templates, in some embodiments, include an adhesive side to allow thetemplate to be held in place on the skin of a patient. In someembodiment, separate adhesives or tapes may be used to hold the templatein place for marking. In some embodiments, tension bands or straps areused to hold the template in place. Some embodiments may use springloaded clips, mechanical hoods and loops, magnets, or any othermechanism for quickly, securely, and easily attaching the templates tothe patient.

Because an applied template intrinsically flattens the underlying flesh,which otherwise is not intrinsically flat, knowing the unstretchedSurface geometry of the tattooed body part is not useful. So even thoughthe geometry of the tattooed body part can be precisely measured (bylaser scanning, for example), the results are not useful. Instead, thegeometry of the tattooed body part must be measured after it isintrinsically flattened by an unstretchable appliance.

This measurement is facilitated by photogrids, which are transparent,relatively unstretchable, appliances overprinted with a grid of thinlines. The color of the grid lines is chosen to stand out against thetattoo it covers. The precise shape and size of the grid is immaterialas long as it is well-known (a one-centimeter square grid is adequate),and the grid itself can be replaced by an array of discrete dots orcrosses, or any other well-defined alignment pattern.

A photogrid is placed on the skin over the tattoo. Photographs aretaken, often from several angles if the tattoo wraps around a curvedbody surface. The grid locates points on the tattoo, which are used tomathematically unwrap the intrinsically flattened tattoo from the bodysurface.

This unwrapping transformation is not difficult. Photogrid locations arefirst located by image processing. The image is then morphed until allthe grid locations (located in the image) return to their originalpositions in an extrinsically flat plane.

The extrinsically flattened tattoo image (that is, it now lies on aplane) is then used in the custom template design process. Once this iscomplete, the template is directly cut or printed without any othergeometric trans formations. When the resulting template is applied overthe tattoo, it will intrinsically flatten the skin precisely as did theoriginal photogrid.

A custom templating process may include various steps including:

1. Photograph the tattoo overlaid by a photogrid applied to the skin;

2. Import the photograph into a computer via a computer program;

3. Image process the photograph to find the photogrid alignment markers;

4. Morph the image so that the photogrid alignment markers overlay theiroriginal grid positions on an extrinsically flat Surface. This morphingflattens the tattoo image (producing a morphed image);

5. Display the flattened tattoo image, so the technician can outline thetattoo elements selected for removal;

6. Once the removal region is defined, the computer program generates acustom tiling series (and potentially custom primary and secondarytemplates);

7. Primary and secondary templates are directly cut or printed bycomputer-controlled, commercially-available devices;

8. For the first treatment, the primary template is aligned with theselected tattoo element and then TEPR treated;

9. For the second treatment, the secondary template is aligned with theprimary, healed-skin, polka dots. Extegs that fall within the selectedarea are marked and TEPR treated as previously described. Boundaryextegs are carefully excised to remove only the tattoo elements selectedfor removal;

10. For the final treatment, ink remaining within the selected tattooelement is directly removed. Simply treat the ink.

FIGS. 1-2, and 4-11 depict scales on the x-axis and y-axis inmillimeters. Although drawn to scale, embodiments may include varyingsize of apertures and varying distances between apertures are notlimited to the scale of the drawings depicted and described herein.

Keratinocytes proliferate to cover a fresh wound at rates determined bythe natural growth and cell-cycle time governing mitosis (non-gameticcellular division). Thus, when the minimum linear or areal extent of thewound is large, epithelialization is delayed. This can result infibrosis, hypertrophic scarring, and poor healing. A goal ofmicroneedling may be to produce wounds in spatial patterns that areconducive to both healing and minor blood scabbing. When wounds are toosmall, the microneedling process may not be effective. When wounds aretoo large, the skin may be damaged, and scarring may prevail.

Referring to FIGS. 12-13 , in one embodiment, a template 1200, which maybe adhered to the skin, is used to control the depth of a needle group,prevent lateral wandering of a needle group, and create a structured,patterned procedure to remove skin irregularities. For example, skinirregularities that may be removed include skin lesions, pigmentedlesions, scarring, acne, stretch marks, or any other irregularity of theskin. Skin irregularities can be removed through a micro or macroneedling process. Puncturing the skin with, for example, a microneedlecan encourage the skin to produce new skin in its place.

Microneedling may involve a group of small needles, or individualneedles, that puncture the epidermis and dermis at a predetermineddepth. When the epidermis and dermis are punctured, the underlyingcells, epidermal cells and dermal fibroblasts, are only minimallydamaged, which creates a minor immune response initiating blood flow tothe dermis. After the epidermis and dermis have been punctured, immunecells (white blood cells) and transforming growth factor beta-3 arestimulated and are necessary in the creation and regulation of new cellgrowth. Further, the puncture channels created by the microneedlesstimulate fibroblasts to create new collagen, allowing the epidermis tohave a smoother, fuller surface and better elastic properties after thehealing process. The depth and pattern of the needle group is important.The correct depth of the needle group and pattern of puncturing can leadto effective collagen production and healing. Without the template 1200,a user is left to determine their own pattern to puncture the epidermisand dermis, which may lead to areas of the skin that have been puncturedtoo much or not enough. A user may also puncture the skin too deepcausing significant trauma to the underlying cells and reducing theeffectiveness of the treatment.

Accordingly, it may be advantageous to use a template that has athickness that can assist a user in controlling the depth of a needle,allowing a user to puncture the epidermis and dermis at a consistentdepth. It should be noted that the depth of the needle group may also beadjusted on the needle device. The template 1200 comprises a pluralityof needle apertures 1202 to create a structured procedure, an adhesivelayer 1204, and a release liner 1206. The release liner 1206 may beremoved, exposing the adhesive layer 1204, so that the template 1200,with the plurality of needle apertures 1202, may be positioned over theskin irregularity. The template 1200 can provide a structured approachto removing many skin irregularities and tattoos found on the epidermis.

The template 1200 can be square shaped; however, it will be appreciatedthat the template 1200 can be many other shapes, such as circular (FIG.14 ), rectangular, etc. Further, it will be appreciated that, in oneembodiment, the shape of the template 1200 may be similar in shape andsize to the skin irregularity to provide the most control during aprocedure. For example, as shown in FIG. 15 , an oval shaped templatemay be used with a long skin irregularity on the epidermis so that theentire skin irregularity is covered, without having too much templateoverlap onto non-irregular skin.

The template 1200 may be a sheet of material 1208, which may be made ofsilicone, polypropylene, or any other material. In some embodiments, thesheet of material 1208 may be flexible to conform to a non-flat surfaceof skin on a patient. In some embodiments, the sheet of material 1208may be flexible while not stretching. That is, the distance between theplurality of needle apertures 1202 does not increase through stretchingin a transverse direction between the plurality of needle apertures1202. In some embodiments, the template 1200 is cut or missing portionsof the sheet of material 1208 in order for the template 1200 to conformto any shape of skin irregularity or protrusion of the epidermis, suchas the nose or chin.

The template 1200 may vary in length, width, and height. There may be,for example, a template that is 1″×1″, a template that is 6″×6″, or anyother sized template. In one embodiment, the template 1200 may be 4/3inch×1 inch, with the needle apertures being 1.67 mm diameter disks,which are spaced apart 2.67 mm from the center of the aperture. Inaddition, the needle apertures may combine to cover approximately 35percent of a unit cell, and the total count of needle apertures is 138.

The thickness of the template may assist a user in controlling the depthof the needle or needle group. In particular, the needle apertures 1202control the depth as discussed below. Accordingly, controlling the depthof the needles assists a user in different procedures and provides theoptimal puncture depth, a depth where cell damage is limited. This canallow for improved effectiveness in the microneedling process, and aquicker healing of the dermal and epidermal layers. It should be notedthat the depth of the needle or needle group may also be controlled byextending and retracting the needle group on a needle device, which canadd more control and adjustability in puncturing the epidermis anddermis.

In one embodiment, the thickness of the template may vary from one sideto the opposite side to account for variations in the depth of theepidermis, especially on the face. If a skin lesion covers the thin andthick epidermal areas of the face, a user may not be able to use thesame depth for the needle group due to the variations in epidermalthickness. For example, one side of the template may be thin in order tooffer a greater puncturing depth on the thicker flesh above portions ofthe mandible, while the opposite side may be thicker in order to offerless puncturing depth for thinner flesh positioned over the sphenoid orfrontal bones.

Further, the template 1200 may include the plurality of needle apertures1202. The plurality of needle apertures 1202 may be disk shaped andspaced in a rhomboid pattern. The plurality of needle apertures 1202 maybe small; however, they may also be large or any other size. Inaddition, as shown in FIG. 16 , the plurality of needle apertures 1202may be evenly distributed on the template 1200 in a linear pattern. Insome embodiments, the plurality needle apertures 1202 may be in otherpatterns and shapes, such as a circular pattern with square apertures orcircular apertures. It should be noted that the patterns and shapes ofthe needle apertures may be in any pattern or shape to assist a user.

Referring back to FIG. 12 , the plurality of needle apertures 1202 canprovide a location for a needle group to enter the epidermis and dermis,for example, to remove a skin irregularity through simply puncturing theepidermis and dermis to stimulate collagen production, or to introducefluid, via the puncture channels, to remove a tattoo, such as a shallowtattoo in the eyebrows. The plurality of needle apertures 1202 are of adiameter that is large enough to allow the needle or group of needles toenter, but small enough to prevent a needle cartridge tube fromentering. This allows a controlled procedure where a user can insert theneedle group to the same depth, until the needle cartridge tube contactsan upper surface 1212 of the template 1200, in each of the plurality ofneedle apertures 1202. Further, in an alternate embodiment the pluralityof needle apertures 1202 may be useful in preventing damage to theepidermis. For example, each of the plurality of needle apertures 1202may receive the cartridge tube, securing the cartridge tube and theneedle group in a single location and preventing lateral movement. Thiswould prevent the needle group from wandering laterally across theepidermis. Additionally, a user must lift the needle group above theupper surface 1212 of the template 1200 in order to place it in anotherneedle aperture, which prevents the user from accidentally dragging theneedle group across the epidermis. In contrast, without the template1200, a user may drag the needle group, or the needle group may wanderwhen performing the microneedling procedure, causing damage to theepidermis. It will be appreciated that the needle apertures 1202 can bea variety of shapes, patterns, and sizes so as to receive numerousgauges of needles and be used on a variety of skin irregularities ortattoos.

The adhesive layer 1204 (FIG. 13 ), on a lower surface 1210 of the sheetof material 1208, allows the template 1200 to be held in place on theskin of a patient. The adhesive layer 1204 may comprise any suitableadhesive. For example, the adhesive layer 1204 may be an acrylate,including methacrylates and epoxy diacrylates. Alternatively, theadhesive layer 1204 may be a silicone based adhesive. The adhesive layermay be coextensive with the lower surface 1210, in a pattern, or anyother manner on the lower surface 1210 surrounding the plurality ofneedle apertures 1202. In some embodiments, separate adhesives or tapesmay be used to hold the template in place. In some embodiments, tensionbands or straps are used to hold the template in place, or any othermechanism for quickly, securely, and easily attaching the template tothe patient. Further, the release liner 1206 may releasably adhere tothe adhesive layer 1204. The release liner 1206 may protect the adhesivelayer 1204 from prematurely adhering to an undesired location and may beremoved from the template 1200 prior to application on the epidermis.

To use the template 1200, a user would remove the release liner 1206,exposing the adhesive layer 1204. Then the user would apply the template1200 over a skin irregularity on a patient. The user can thensystematically place the needle group into each of the plurality ofneedle apertures 1202 to puncture the skin to a depth until the needlecartridge tube contacts the upper surface 1212 of the template 1202.Once all of the plurality of needle apertures 1202, or a portion of theplurality of needle apertures, have been addressed, the user can removethe template 1200. This process could be performed multiple times. Forexample, after the first treatment, the user can move the template 1200and repeat the same process, which can lead to more collagen productionand ridding the epidermis of skin irregularities. Specifically, in asecond treatment the user could move the template 1200 so that theplurality of needle apertures 1202 overlap the previously punctured skinchannels. It should be noted that a second treatment may not need to bea full treatment. For example, the second treatment may only requirethat half, or any other amount, of the plurality of needle apertures1202 be addressed by the needle group. After the treatments, newcollagen and epidermis can begin to replace the skin irregularity.

Referring to FIG. 17 , in one embodiment, a large template 1300comprises a plurality of needle apertures 1302, wherein the plurality ofneedle apertures 1302 are large apertures 1304. The large apertures 1304may accommodate macro needles, large microneedle groups, or other largerneedles. In some circumstances, macro needles can be used to increasecollagen production for large areas of skin. At times, the larger needleapertures and larger template could be used to stimulate collagen andelastin production to remove, for example, wrinkles. It should be notedthat the increase in needle size can also mean an increase in tubingsize. While the tubing size increases, it will be prevented, like thesmaller tubing, from entering the needle apertures in order to controlthe depth of the needle group.

In the above description, certain terms may be used such as “up,”“down,” “upwards,” “downwards,” “upper.” “lower,” “horizontal,”“vertical,” “left,” “right,” “over.” “under and the like. These termsare used, where applicable, to provide Some clarity of description whendealing with relative relationships. But, these terms are not intendedto imply absolute relationships, positions, and/or orientations. Forexample, with respect to an object, an “upper” surface can become a“lower surface simply by turning the object over. Nevertheless, it isstill the same object. Further, the terms “including.” “comprising,”“having,” and variations thereof mean “including but not limited tounless expressly specified otherwise. An enumerated listing of itemsdoes not imply that any or all of the items are mutually exclusiveand/or mutually inclusive, unless expressly specified otherwise. Theterms “a,” “an, and “the also refer to “one or more’ unless expresslyspecified otherwise. Further, the term “plurality’ can be defined as “atleast two.”

Additionally, instances in this specification where one element is“coupled to another element can include direct and indirect coupling.Direct coupling can be defined as one element coupled to and in somecontact with another element. Indirect coupling can be defined ascoupling between two elements not in direct contact with each other buthaving one or more additional elements between the coupled elements.Further, as used herein, securing one element to another element caninclude direct securing and indirect securing. Additionally, as usedherein, “adjacent does not necessarily denote contact. For example, oneelement can be adjacent another element without being in contact withthat element.

As used herein, the phrase “at least one of when used with a list ofitems, means different combinations of one or more of the listed itemsmay be used and only one of the items in the list may be needed. Theitem may be a particular object, thing, or category. In other words, “atleast one of means any combination of items or number of items may beused from the list, but not all of the items in the list may berequired. For example, “at least one of item A, item B, and item C maymean item A; item A and item B; item B; item A, item B, and item C.; oritem B and item C. In some cases, “at least one of item A, item B, anditem C may mean, for example, without limitation, two of item A, one ofitem B, and ten of item C:, four of item B and seven of item C; or someother suitable combination.

Unless otherwise indicated, the terms “first,” “second,’ etc. are usedherein merely as labels, and are not intended to impose ordinal,positional, or hierarchical requirements on the items to which theseterms refer. Moreover, reference to, e.g., a second item does notrequire or preclude the existence of, e.g., a “first or lower-numbereditem, and/or, e.g., a “third” or higher-numbered item.

As used herein, a system, apparatus, structure, article, element,component, or hardware “configured to perform a specified function isindeed capable of performing the specified function without anyalteration, rather than merely having potential to perform the specifiedfunction after further modification. In other words, the system,apparatus, structure, article, element, component, or hardware“configured to perform a specified function is specifically selected,created, implemented, utilized, programmed, and/or designed for thepurpose of performing the specified function. As used herein,“configured to denotes existing characteristics of a system, apparatus,structure, article, element, component, or hardware which enable thesystem, apparatus, structure, article, element, component, or hardwareto perform the specified function without further modification. Forpurposes of this disclosure, a system, apparatus, structure, article,element, component, or hardware described as being “configured toperform a particular function may additionally or alternatively bedescribed as being “adapted to and/or as being “operative to performthat function.

The schematic flow chart diagrams and method schematic diagramsdescribed above are generally set forth as logical flow chart diagrams.As such, the depicted order and labeled steps are indicative ofrepresentative embodiments. Other steps, orderings and methods may beconceived that are equivalent in function, logic, or effect to one ormore steps, or portions thereof, of the methods illustrated in theschematic diagrams.

Additionally, the format and symbols employed are provided to explainthe logical steps of the schematic diagrams and are understood not tolimit the scope of the methods illustrated by the diagrams. Althoughvarious arrow types and line types may be employed in the schematicdiagrams, they are understood not to limit the scope of thecorresponding methods. Indeed, some arrows or other connectors may beused to indicate only the logical flow of a method. For instance, anarrow may indicate a waiting or monitoring period of unspecifiedduration between enumerated steps of a depicted method. Additionally,the order in which a particular method occurs may or may not strictlyadhere to the order of the corresponding steps shown.

The present subject matter may be embodied in other specific formswithout departing from its spirit or essential characteristics. Thedescribed embodiments are to be considered in all respects only asillustrative and not restrictive. All changes which come within themeaning and range of equivalency of the claims are to be embraced withintheir scope.

In the above description, specific details of various embodiments areprovided. However, some embodiments may be practiced with less than allof these specific details. In other instances, certain methods,procedures, components, structures, and/or functions are described in nomore detail than to enable the various embodiments of the invention, forthe sake of brevity and clarity.

Although specific embodiments of the invention have been described andillustrated, the invention is not to be limited to the specific forms orarrangements of parts so described and illustrated. The scope of theinvention is to be defined by the claims appended hereto and theirequivalents.

What is claimed is:
 1. A system for removing a skin marking throughdermal disruption, the system comprising: a needle cartridge comprisinga needle cartridge tube and a needle group; and a template comprising: asheet of material comprising an upper surface and a plurality oftreatment apertures spaced in a repeating pattern throughout the sheetof material, wherein the sheet of material is flexible and conforms to anon-flat surface of skin on a patient; an adhesive layer positioned on alower surface of the sheet of material, wherein the adhesive layer iscoextensive with the lower surface, circumscribing the plurality oftreatment apertures; and a release liner coupled to the adhesive layer;wherein each of the plurality of treatment apertures receives the needlegroup of the needle cartridge that punctures the skin of a patient to apredetermined depth at which the needle cartridge tube of the needlecartridge contacts the upper surface of the template, and wherein thecontact between the needle cartridge tube and the upper surface is usedto control the predetermined depth of the needle group.
 2. The templateof claim 1, wherein each of the plurality of treatment apertures is diskshaped.
 3. The template of claim 1, wherein the plurality of treatmentapertures are arranged in a rhomboid pattern.
 4. The template of claim1, wherein the skin marking comprises a tattoo.
 5. The template of claim1, wherein the skin marking comprises a skin irregularity.
 6. Thetemplate of claim 5, wherein the skin irregularity comprises a skinlesion.
 7. The template of claim 5, wherein the skin irregularitycomprises a stretch mark.
 8. The template of claim 1, wherein the needlegroup of the needle cartridge punctures and shears the skin of a patientto a predetermined depth.
 9. A system for removing a skin markingthrough dermal disruption, the system comprising: a needle cartridgecomprising a needle cartridge tube and a needle group; and a templatecomprising: a sheet of material comprising a plurality of treatmentapertures spaced in a repeating pattern throughout the sheet ofmaterial, wherein each of the plurality of treatment apertures receivesthe needle group of the needle cartridge that punctures the skin of apatient to a predetermined depth at which the needle cartridge tube ofthe needle cartridge contacts an upper surface of the template; anadhesive layer positioned on a lower surface of the sheet of material;and a release liner coupled to the adhesive layer; wherein the contactbetween the needle cartridge tube and the upper surface is used tocontrol the predetermined depth of the needle group.
 10. The template ofclaim 9, wherein the sheet of material comprises a side length of 1 to 2inches.
 11. The template of claim 9, wherein the sheet of material isflexible and conforms to a non-flat surface of skin on a patient. 12.The template of claim 9, wherein the plurality of treatment aperturesare disk shaped.
 13. The template of claim 12, wherein the diskapertures each comprise a diameter of 1 to 2 mm and are spaced apart 2to 3 mm from a center of the aperture.
 14. The template of claim 9,wherein the plurality of treatment apertures are equal in size to amacro needle.
 15. The template of claim 9, wherein the plurality oftreatment apertures are spaced in a rhomboid pattern.
 16. The templateof claim 9, wherein the plurality of treatment apertures are spaced in asquare pattern.
 17. A method for removing a skin marking through dermaldisruption, the method comprising: removing a release liner from atemplate, exposing an adhesive layer; adhering the template including aplurality of treatment apertures over a skin marking on a patient;inserting a needle group into each of the plurality of treatmentapertures to a predetermined depth at which a needle cartridge tubecontacts an upper surface of the template; and removing the templatefrom the skin marking of the patient; wherein the contact between theneedle cartridge and the upper surface is used to control thepredetermined depth of the needle group.
 18. The method of claim 17,wherein the template is flexible to conform to a non-flat surface ofskin on a patient.
 19. The method of claim 17, wherein a position of thetemplate is adjusted to puncture untreated skin in a second treatment.20. The method of claim 19, wherein the second treatment is a partialtreatment.